Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma

Dartmouth Health

Status and phase

Withdrawn

Phase 2

Conditions

Adrenocortical Carcinoma

Treatments

Drug: Bevacizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00469469

DMS 0510

Details and patient eligibility

About

This is a Phase II study of intravenous Bevacizumab in patients with pathologically confirmed nonresectable primary adrenocortical cancer (ACC). Patients must have received no prior therapy. They will receive Bevacizumab as a single agent every 2 weeks intravenously until disease progression. This study will be open at multiple sites.

Full description

Adrenocortical carcinoma(ACC)is a rare malignancy with an incidence of 1.5 to 2 per million per year in the United states. Surgery is the only therapeutic option that can prolong survival. Currently there are no therapies that have been proven to prolong survival for patients with nonsurgically resectable disease. ACC has been shown to be highly resistant to standard chemotherapy, therefore, it is important that we test agents with mechanisms of action. This is a single arm phase II study of Bevacizumab, an angiogenesis inhibitor, given as a single agent at 10 mg/kg IV every 2 weeks in patients with unresectable ACC. Bevicizumab will be used as first line therapy. The study will test if Bevacizumab will be able to prolong the time to progression. If a delay in time to progression of 4 months or greater is seen, this will be considered clinically meaningful and further studies will be considered. This study will be conducted at multiple institutions (see below).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must provide written informed consent
Subjects must be 18 years of age or older
Subjects must have histologically confirmed ACC by the Department of Pathology at Dartmouth-Hitchcock Medical Center
Subjects must have inoperable disease
This is a first and/or second line study. Patients must have completed only one or fewer regimes of systemic therapy. They may have received one prior systemic therapy either: a) mitotane, or b)chemotherapy, or c) experimental therapy, or d) concurrent chemotherapy and mitotane, or e) no prior systemic therapy
Subjects must have a life expectancy of three or more months
If subjects have received some form of systemic therapy (e.g. chemotherapy or mitotane), they should have completed that systemic therapy at least 28 days before beginning Bevacizumab
All subjects of child-bearing potential(men and women) must agree to the use of effective means of contraception

Exclusion criteria

Other co-existing malignancies or malignancies diagnosed within the last 5 years wtih the exception of basal cell carcinoma or cervical cancer in situ
Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy (except alopecia)
absolute neutrophil counts less than 1.5 x l,000,000,000/liter, or platelets less than 20.0 x 1,000,000,000/liter
As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory,cardiac, hepatic, or renal disease)
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial
Prior therapy with two or more systemic therapy regimes. In other words if a patient is seeking third line therapy or later than third line therapy he is ineligible for this study
Current, recent(within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech- sponsored Bevacizumab cancer study
Prior use of Bevacizumab or any other anti-VEGF therapies
Known hypersensitivity to Bevacizumab
Inadequately controlled hypertension (defined as systolic blood pressure of >150 mm Hg and/or diastolic blood pressure >100 mm Hg on anti- hypertensive medications
Any prior history of hypertensive crisis or hypertensive encephalopathy
Unstable angina
New York Heart Association (NYHA)Grade II or greater congestive heart failure
History of myocardial infarction within 6 months
History of stroke or transient ischemic attack at any time prior to study enrollment
Clinically significant peripheral vascular disease
Evidence of bleeding diathesis or coagulopathy
Presence of central nervous system or brain metastases
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
Core biopsies or other minor surgical procedures, excluding placement of a vascular access device, within 7 days prior to Day 0
Pregnant (positive pregnancy test) or lactating
Women who are fertile and not willing to practice abstinence or an adequate form of contraception (i.e. use or oral contraceptives, intrauterine devices or barrier protection)
Urine protein: creatinine ratio > 1.0 at screening -History of abdominal fistula, gastrointestinal perforation, or intr- abdominal abcess within 6 months prior to Day 0
Serious, non-healing wound, ulcer, or bone fracture
Lung lesions of any etiology(malignant or nonmalignant) in close proximity to a major vessel
Cavitary lung lesions (to prevent episodes of potentially life-threatening hemoptysis)
History of hemoptysis (defined as bright red blood of 1/2 teaspoon or more)
Inability to comply with study and/or follow-up procedures